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KYPROLIS Drug Profile
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Which patents cover Kyprolis, and what generic alternatives are available?
Kyprolis is a drug marketed by Onyx Therap and is included in one NDA. There are eleven patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and eighty-eight patent family members in thirty-six countries.
The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.
Summary for KYPROLIS
| International Patents: | 188 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 52 |
| Clinical Trials: | 50 |
| Patent Applications: | 179 |
| Drug Prices: | Drug price information for KYPROLIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KYPROLIS |
| DailyMed Link: | KYPROLIS at DailyMed |
Generic Entry Opportunity Date for KYPROLIS
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for KYPROLIS
| Drug Class | Proteasome Inhibitor |
| Mechanism of Action | Proteasome Inhibitors |
Synonyms for KYPROLIS
| (2S)-4-methyl-N-[(2S)-1-[[(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]-2-[[(2S)-2-[(2-morpholin-4-ylacetyl)amino]-4-phenylbutanoyl]amino]pentanamide |
| (2S)-N-((1S)-1-Benzyl-2-(((1S)-3-methyl-1-(((2R)-2-methyloxiran-2-yl)carbonyl)butyl)amino)-2-oxoethyl)-4-methyl-2-(((2S)-2-((morpholin-4-ylacetyl)amino)-4-phenylbutanoyl)amino)pentanamide |
| (2S)-N-[(1S)-1-benzyl-2-[[(1S)-3-methyl-1-[(2R)-2-methyloxirane-2-carbonyl]butyl]amino]-2-oxo-ethyl]-4-methyl-2-[[(2S)-2-[(2-morpholinoacetyl)amino]-4-phenyl-butanoyl]amino]pentanamide |
| (Alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phe nylalaninamide |
| (alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phenylalaninamide |
| (S)-4-methyl-N-((S)-1-(((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamide |
| (S)-4-Methyl-N-((S)-1-((S)-4-Methyl-1-((R)-2- Methyloxiran-2-yl)-1 -oxopentan-2-ylaMino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-MorpholinoacetaMido)-4-phenylbutanaMido)pentanaMide |
| 72X6E3J5AR |
| 868540-17-4 |
| AB0008111 |
| AB01565867_02 |
| AC-27051 |
| AKOS025401910 |
| AN-217 |
| AOB87759 |
| AS-17059 |
| BC251806 |
| BDBM50277889 |
| BLMPQMFVWMYDKT-NZTKNTHTSA-N |
| C40H57N5O7 |
| Carfilzomib |
| Carfilzomib (JAN/USAN/INN) |
| Carfilzomib (PR-171) |
| Carfilzomib [USAN:INN] |
| Carfilzomib?PR-171?/Kyprolis |
| Carfilzomib(PR171) |
| CAS-868540-17-4 |
| CHEBI:65347 |
| CHEMBL451887 |
| CS-0984 |
| CS-W004540 |
| D00UVA |
| D08880 |
| DB08889 |
| DSSTox_CID_28616 |
| DSSTox_GSID_48690 |
| DSSTox_RID_82886 |
| DTXSID4048690 |
| FT-0696769 |
| GTPL7420 |
| HY-10455 |
| J-501773 |
| KB-75946 |
| KS-00000SR1 |
| Kyprolis (TN) |
| L-Phenylalaninamide, (alphaS)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-L-leucyl-N-((1S)-3-methyl-1-(((2R)-2-methyloxiranyl)carbonyl)butyl)- |
| MFCD11040997 |
| MLS006011102 |
| MolPort-027-950-907 |
| N-{(2S)-2-[(morpholin-4-ylacetyl)amino]-4-phenylbutanoyl}-L-leucyl-N-{(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl}-L-phenylalaninamide |
| NCGC00249613-01 |
| NCGC00249613-02 |
| NCGC00249613-03 |
| ONO-7057 |
| PR 171 |
| PR-171 |
| PX-171-007 |
| QCR-96 |
| RL05381 |
| S-7798 |
| s2853 |
| SC-91032 |
| SCHEMBL85165 |
| SMR004660024 |
| SR-01000941582 |
| SR-01000941582-1 |
| Tox21_113079 |
| Tox21_113079_1 |
| UNII-72X6E3J5AR |
| Y0441 |
| ZINC49841054 |
US Patents and Regulatory Information for KYPROLIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-002 | Jun 3, 2016 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-003 | Jun 7, 2018 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-002 | Jun 3, 2016 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Paragraph IV (Patent) Challenges for KYPROLIS
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | For Injection | 30 mg/vial | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | For Injection | 60 mg/vial | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for KYPROLIS
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,198,270 | Compounds for proteasome enzyme inhibition | ➤ Sign Up |
| 8,088,741 | Compounds for enzyme inhibition | ➤ Sign Up |
| 8,324,174 | Compounds for enzyme inhibition | ➤ Sign Up |
| 8,207,124 | Compounds for enzyme inhibition | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for KYPROLIS
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2011148805 | ➤ Sign Up |
| South Korea | 20160033795 | ➤ Sign Up |
| Ukraine | 104600 | ➤ Sign Up |
| New Zealand | 603739 | ➤ Sign Up |
| Spain | 2359004 | ➤ Sign Up |
| Russian Federation | 2615385 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for KYPROLIS
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2016010,C1781688 | Lithuania | ➤ Sign Up | PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119 |
| 015 | Luxembourg | ➤ Sign Up | PRODUCT NAME: CARFILZOMIB EVENTUELLEMENT SOUS FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151123 |
| 16/013 | Ireland | ➤ Sign Up | PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/15/1060 20151119 |
| 0805 | Netherlands | ➤ Sign Up | PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 20151123 |
| C0017 | France | ➤ Sign Up | PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: EU/1/15/1060 20151123 |
| 0160008 00189 | Estonia | ➤ Sign Up | PRODUCT NAME: KARFILSOMIIB;REG NO/DATE: EU/1/15/1060 23.11.2015 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
